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Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field. Magnetic resonance imaging (MRI). Patients should cautiously approach such devices and should request help to bypass them. Using surgical instruments. Neuromodulation. Sheath rotation. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Control of the patient controller. Thorough psychiatric screening should be performed. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Security, antitheft, and radiofrequency identification (RFID) devices. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. If the sheath is not responding to rotation, do not rotate the steering wing out of plane from the curve of the sheath more than 90 degrees. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. Care and handling of components. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. Confirm that no adverse conditions to MR scanning are present. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation. Failure to do so may result in damage to the sheath. If the programming of stimulation parameters exceeds the charge density limit of 30 C/cm2, a screen will appear warning you that the charge density is too high. Advance the needle and guidewire slowly. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Mobile phones. commercial electrical equipment (such as arc welders and induction furnaces). In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). The following precautions apply to this neurostimulation system. Patient selection. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for six to eight weeks after implantation of a neurostimulation system. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which some patients have described as uncomfortable or jolting. 71409MAT-2116350 v4.0 | Item approved for U.S. use only. Follow proper infection control procedures. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . Careful consideration should be used before using radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system since safety has not been established. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. If lithotripsy must be used, do not focus the energy near the IPG. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Patient training. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. For more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for neurostimulation systems(available online atmedical.abbott/manuals). Advise patients who experience these types of stimulation changes to turn down the amplitude or turn off the IPG before making extreme posture changes or abrupt movements such as stretching, lifting their arms over their heads, or exercising. If a system does not meet the MR Conditional requirements, consider it MR Unsafe. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Sheath insertion precaution. Lead handling. Infection. Charge density can be reduced by lowering the stimulation amplitude or pulse width. *Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study. INDICATIONS FOR USE The safety and effectiveness of neurostimulation for pediatric use have not been established. Patients using therapy that generates paresthesia should turn off stimulation before operating motorized vehicles, such as automobiles, or potentially dangerous machinery and equipment because sudden stimulation changes may distract them from properly operating it. Return all explanted components to Abbott Medical for safe disposal. Wireless use restrictions. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. Exposure to body fluids or saline. For more information about MR Conditional deep brain stimulation (DBS) components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for DBS systems(available online atmedical.abbott/manuals). FDA's expanded . However, some patients may experience a decrease or increase in the perceived level of stimulation. Component disposal. The system is intended to be used with leads and associated extensions that are compatible with the system. Application modification. Securing the IPG. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. The device should be turned off and the doctor contacted if this occurs. Make the Bold Choice Advise patients about adverse effects. Lasting Relief through our smallest system yet. Patient's visual ability to read the patient controller screen. Clinician training. During the implant procedure, if an electrosurgery device must be used, take the following actions:. The system is intended to be used with leads and associated extensions that are compatible with the system. Explosive and flammable gasses. Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which some patients have described as uncomfortable or jolting. The patient must be instructed to not rub or exert pressure on implanted components through the skin as this may cause lead dislodgement leading to stimulation at the implant site, IPG inversion leading to the inability to communicate with the device, or skin erosion that can lead to another surgical procedure or possible infection. Failure to do so may cause harm to the patient such as damage to the dura. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Component manipulation by patients. The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death. Jude, Medtronic).Most of the early models of these devices were considered MR Unsafe primarily due to the theoretical risk of spinal cord injury from heating of the the electrode tip by RF-induced currents (the so-called antenna effect). Stimulation effectiveness has been established for one year. High-output ultrasonics and lithotripsy. However, advise patients who feel uncomfortable paresthesia during postural changes that they should not operate potentially dangerous equipment such as power tools, automobiles, or other motor vehicles. Securing the lead with the lead stabilizer will mitigate this risk. For more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for neurostimulation systems (available online atmedical.abbott/manuals). Lead movement. The effect of mobile phones on deep brain stimulation is unknown. At the core of this patient-centric advancement is a battery that can last up to 10 years at low-dose settings** without the hassles of recharging. Sheath retraction. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. Conscious sedation during removal. High stimulation outputs. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. Stabilizing the lead during insertion. Equipment is not serviceable by the customer. This neurostimulation system is contraindicated for patients who are. For this reason, programming at frequencies less than 30 Hz is not recommended. Guidance and conditions for MRI safety with neuromodulation systems, neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html, Upper buttock, low back, midline, flank or abdomen, Upper buttock, low back, flank, or abdomen, 6170 directional lead, 30 cm, 0.5-mm spacing, black, Fully implanted in the brain, routed under the scalp, 6010 Guardian cranial burr hole cover system, Fully implanted in the brain, routed under the scalp and connected to an extension, Head and neck, routed to the IPG on the same side of the body as the IPG, Lead-only systems, which consist of at least one implanted lead connected to a lead protection boot, as well as an optional cranial burr hole cover, Full systems, which consist of at least one implantable pulse generator (IPG), lead and extension, as well as an optional cranial burr hole cover. Do not suture directly onto the lead to avoid damaging the lead. High-output ultrasonics and lithotripsy. Recharge-by date. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Patients should not be dependent on drugs and should be able to operate the neurostimulation system. Do not use excessive force to push the lead or sheath into the neural foramen as this may result in permanent or transient nerve damage. Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage system components. Extension of the upper torso or neck may cause lead movement and alter the stimulation field (especially with leads in the cervical area), resulting in overstimulation or ineffective stimulation. Case damage. Scuba diving or hyperbaric chambers. Infections related to system implantation might require that the device be explanted. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. High stimulation outputs and charge density limits. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which some patients have described as uncomfortable or jolting. If the implanted system contains any other components or models than what appears in the following tables, then the system is considered untested for an MRI environment. Component manipulation by patient. Household appliances that contain magnets (e.g., refrigerators, freezers, inductive cooktops, stereo speakers, mobile telephones, cordless telephones, standard wired telephones, AM/FM radios, and some power tools) may unintentionally cause the neurostimulation system to turn on or turn off. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Component fracture or dislodgement may result in loss of stimulation, intermittent stimulation, stimulation at the fracture site, and additional surgery to replace or reposition the component. Keep dry to avoid damage. If you are unsure of the policy that applies to the use of this device, please ask for authorization to use it before turning it on. Removing each item in slow movements while holding the remaining components in place will assist this process. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. Electrosurgery. Do not use surgical instruments to handle the lead. Risk of depression, suicidal ideations, and suicide. Stimulation effectiveness. Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. Wireless use restrictions. Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. Failure to do so can damage or cut the lead or sheath. Free from the hassles of recharging. Wireless use restrictions. The Proclaim XR SCS System is an implantable spinal cord stimulation device designed to allow patients to attain relief from chronic pain of the trunk and limbs. Infection. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Emergency procedures. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. Closely monitor patients for signs of infection, delayed wound healing, or cerebrospinal fluid (CSF) leakage as the severity of these complications may be greater in patients with diabetes. If use of electrocautery is necessary, place the neurostimulator in Surgery mode using the clinician programmer app or the patient controller app before using an electrosurgery device. Providing strain relief. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. For specific indications, contraindications, instructions, warnings, precautions, and adverse effects about system components available in your country or region, see the approved clinician's manual for those components. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Safety and effectiveness has not been established for patients with a neurological disease other than Parkinsons disease or essential tremor, previous surgical ablation procedures, dementia, coagulopathies, or moderate to severe depression; patients under 22 years; implantation in targets other than the STN for Parkinson's disease and the VIM for essential tremor; patients with an active implantable device; patients requiring MRI. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. The IPG should be explanted before cremation because the IPG could explode. For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which some patients have described as uncomfortable or jolting. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Important note: For CT procedures that require scanning over the medical device continuously for more than a few seconds, as with CT perfusion or interventional exams, attending staff should be ready to take emergency measures to treat adverse reactions if they occur. External defibrillators. However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Keep the device dry. Ensure the patients neurostimulation system is in MRI mode. Bathing. Operation of machines, equipment, and vehicles. Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device. Skydiving, skiing, or hiking in the mountains. Patients should cautiously approach such devices and should request help to bypass them. In rare cases, this can create a medical emergency. Programmer and controller devices are not waterproof. Activities requiring excessive twisting or stretching. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. Bending the sheath. Application modification. The long-term effectiveness of dorsal root ganglion (DRG) stimulation has not been documented, and not all patients realize the long-term benefits from DRG stimulation. Do not use excessive pressure when injecting through the sheath. Neurostimulation systems have materials that come in contact or may come in contact with tissue. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions. Nerve damage may result from traumatic or surgical nerve injury. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. Security, antitheft, and radiofrequency identification (RFID) devices. Overcommunicating with the IPG. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the device and has trained the patient how to control stimulation and safely use the system. Placement of lead connection in neck. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Learn more about the scan details for our MR Conditional products below. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Device modification. If they must go through a gate or doorway containing this type of device, patients should turn off their IPG and proceed with caution, being sure to move through the device quickly. Precision Spectra Spinal Cord Stimulator System Innovation Focused on Pain Relief Designed for more coverage, more flexibility, and advanced control, the Precision Spectra SCS System is engineered to provide more pain relief to a broader spectrum of patients. After defibrillation, confirm the neurostimulation system is still working. The equipment is not serviceable by the customer. Therapeutic radiation may damage the electronic circuitry of an implanted neurostimulation system, although no testing has been done and no definite information on radiation effects is available. Store components and their packaging where they will not come in contact with liquids of any kind. Abbott offers two types of MR Conditional, fully implanted DBS configurations: WARNING: For an MR Conditional system, all implanted components must be approved MR Conditional models. Always perform removal with the patient conscious and able to give feedback. Do not resterilize or reimplant an explanted system for any reason. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training for dorsal root ganglion (DRG) neurostimulation systems. The clinician programmer and patient controller are not waterproof. Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage system components. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. External defibrillators. Diathermy is further prohibited because it may also damage the neurostimulation system components. Patients should avoid getting too close to these types of EMI sources, which include the following examples: commercial electrical equipment (such as arc welders and induction furnaces), communication equipment (such as microwave transmitters and high-power amateur transmitters), high-voltage power lines, radiofrequency identification (RFID) devices, and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. The IPG should be placed into the pocket, at a depth not to exceed 4 cm (1.57 in), with the logo side facing toward the skin surface. Pregnancy and nursing. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. Use extreme care when removing the lead stylet, the delivery sheath, and the needle to ensure that the distal tip of the lead remains in the desired location. Expiration date. Safety Info ID# Safety Topic / Subject Article Text 294: Spinal Cord Stimulation Systems: St. Jude Medical: Genesis, GenesisXP, GenesisRC, Eon, Eon C, Eon Mini, and Renew The Genesis, GenesisXP, GenesisRC, Eon, EonC, Eon Mini, and Renew neuromodulation devices (St. Jude Medical) used for spinal cord stimul. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Do not use the application if the operating system is compromised (that is, jailbroken). Product materials. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. Devices with one-hour recharge per day. Mobile phones. Output power below 80 W is recommended for all activations. Long-term safety and effectiveness. Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics and induce voltage through the lead that could jolt or shock the patient. Patient selection. If any component of the implanted neurostimulation system, such as an IPG, lead, or extension, does not meet the requirements for an MR Conditional system, do not perform an MRI scan. Physicians should also discuss any risks of MRI with patients. Return all explanted IPGs to Abbott Medical for safe disposal. Always remove the trial leads before implanting the implant leads to avoid the risk of infection that may cause death if the leads are not removed. Read this section to gather important prescription and safety information. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. Therapeutic radiation. Surgeon training. Patients should avoid charging their generator over an incision that has not completely healed. For patients who do not feel paresthesia, sudden stimulation changes are less likely to occur and distract them while operating motorized vehicles, machinery, or equipment. If the lead is unable to deploy out of the sheath, inject sterile water or saline slowly to release tissue that may have entered between the sheath and the lead. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. High altitudes should not affect the neurostimulator; however, the patient should consider the movements involved in any planned activity and take precautions to avoid putting undue stress on the implanted system. If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. Electrocardiograms. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (if either occurs, turn off your IPG immediately. The system is intended to be used with leads and associated extensions that are compatible with the system. The BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. Application modification. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) for the management of intractable, chronic dystonia, including primary and secondary dystonia, for patients who are at least 7 years old. If two systems are implanted, ensure that at least 20 cm (8 in.) Especially consider the following additional factors when selecting patients: Level of available support from a caregiver. To prevent unintended stimulation, do not modify the operating system in any way. Radiofrequency or microwave ablation. Needle insertion. Programmer use. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. If the stylet is removed from the lead, it may be difficult to reinsert it. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. To avoid the risk of skin erosion, implant components at the appropriate depth and inform patients to avoid touching their skin where components are implanted. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. The Eterna SCS System is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain.